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510(k) K822906

PHYSICAL MEDICINE & REHABILITATION EQUIP by I-Rep, Inc. — Product Code ION

K822906 is an FDA 510(k) premarket notification submitted by I-Rep, Inc. for the device "PHYSICAL MEDICINE & REHABILITATION EQUIP". The FDA issued a decision of Substantially Equivalent on October 15, 1982. The device falls under product code ION (Exerciser, Non-Measuring), a Class I device regulated under 21 CFR 890.5370. I-Rep, Inc. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 15, 1982
Date Received
September 29, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Exerciser, Non-Measuring
Device Class
Class I
Regulation Number
890.5370
Review Panel
PM
Submission Type

Other clearances by I-Rep, Inc.

  • K930692 — LATHAM TABLE (February 2, 1994)
  • K930691 — ACCUTRAC TRACTION UNIT (July 22, 1993)
  • K861864 — MEDTRON TYPE P-300 ULTRASONIC THERAPY UNIT (July 14, 1986)
  • K854947 — REHABILITATION TABLES (January 3, 1986)
  • K851690 — ADJUSTABLE TREATMENT TABLES (May 7, 1985)
  • K842268 — VACUPULSE VACUUM UNIT (July 20, 1984)
  • K832940 — ROTAGYM (November 7, 1983)

Other clearances for product code ION

  • K120783 — ABLE-X (June 20, 2012)
  • K885343 — STANDEX (May 1, 1989)
  • K851065 — GRAVITY KING (DEEMED SE 87/09/18) (June 13, 1985)
  • K840551 — MOBILIZER (March 23, 1984)
  • K833870 — KNEE WALKER (November 29, 1983)
  • K833249 — FITNESS (November 7, 1983)
  • K832968 — PEDAL EXERCISER (September 29, 1983)
  • K831543 — ADJUST. WEIGHTS-BK5171-05,10,20 BEOK (June 24, 1983)
  • K831538 — DELUXE ADJUST-ANGLE BOARD-BK4066 (June 8, 1983)
  • K831033 — GIREX (April 27, 1983)

FDA data resources